Scientist, Process Development

2 weeks ago


Montreal, Canada 35Pharma Inc Full time

The Process Development Scientist’s role is to lead new complex protein production industrialization efforts developing upstream processes that are transferable to a CDMOs contracted to produce clinical trial material. The incumbent will develop and optimize upstream processes for biotherapeutics molecules manufacturing, expressed in mammalian CHO cell lines. The role will require an active contribution setting up and operating the mammalian CHO cell production platform of the company.The Process Development Scientist will also be involved in technology transfer and scale-up to CDMOs, as well as the oversight during GMP batch manufacturing campaigns. Other responsibilities are to use best scientific/industrial/regulatory practices in all given projects and integrate the process development effort with the analytical team.This is a full-time maternity leave replacement position for 15 months that reports to the Director of Process Development and is based in Montreal, QC, Canada.Duties and Responsibilities:Participate in manufacturability assessments for new protein candidatesOrganize the preparation of stable pool to express 35Pharma recombinant proteinsPerform transfection, stable pools and transitory cell culture for production of recombinant proteinsPerform early-stage upstream process development/optimization in shake flasks and Bioreactor (e.g.: Wave Bioreactor)Design, develop and optimize upstream manufacturing processes, including CHO cell line development, using a quality by design (QbD) approachPlan and design experiments and write study protocolsResponsible for executing protocols, data analysis and report writingResponsible for maintenance and operation of cell culture laboratory equipmentCoordinate sample testing with the Analytical teamParticipate in the technology transfer and scale-up to contract manufacturing organizationsParticipate in process improvements projects (e.g. process robustness, control and cost of goods (COGs)).Review manufacturing documentation as required and assist in the writing of regulatory submissionsProvide technical/scientific support during GMP manufacturing campaigns, including investigations of non-conformitiesQualifications:Master of Science (M.Sc.) in biochemistry, biotechnology or equivalent with 3 years of relevant experience.Practical Experience with either upstream processes (mammalian cell culture), or the preparation of industrial grade cellular clones.Experience with industrial downstream process development is an assetExperience with scale-down model, design of experiments (DOE) and statistical software is an assetKnowledge of Good Manufacturing Practices in a regulated environmentKnowledge of industrial expression systems, upstream and downstream processes technologiesAbility to work in cross-functional teams and in a fast-paced environmentExperienced in problem solving and troubleshootingExcellent verbal and written communication skills35Pharma is an equal opportunities employer and welcomes applications from all qualified candidates. #J-18808-Ljbffr



  • Montreal, Canada 35Pharma Inc Full time

    The Process Development Scientist’s role is to lead new complex protein production industrialization efforts developing upstream processes that are transferable to a CDMOs contracted to produce clinical trial material. The incumbent will develop and optimize upstream processes for biotherapeutics molecules manufacturing, expressed in mammalian CHO cell...


  • Montreal, Canada 35Pharma Inc Full time

    The Process Development Scientist’s role is to lead new complex protein production industrialization efforts developing upstream processes that are transferable to a CDMOs contracted to produce clinical trial material. The incumbent will develop and optimize upstream processes for biotherapeutics molecules manufacturing, expressed in mammalian CHO cell...


  • Montreal, Canada 35Pharma Inc Full time

    The Process Development Scientist’s role is to lead new complex protein production industrialization efforts developing upstream processes that are transferable to a CDMOs contracted to produce clinical trial material. The incumbent will develop and optimize upstream processes for biotherapeutics molecules manufacturing, expressed in mammalian CHO cell...

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